The mandate of the Data Management and Analysis Core (DMAC) is to direct the planning, design, implementation and testing of the data management system and ensure that all analyses are of high quality and yield statistically valid results. The DMAC will coordinate and integrate efficient and consistent utilization of data and statistical resources across the subprojects by providing standard methodology and staff support that are readily accessible to investigators. DMAC will support each subproject is as follows: Subproject 1 (Clinical efficacy). Data acquisition; Monitoring of data quality and integrity; Auditing of clinical protocols; Enrolment tracking and reporting. Subproject 2 (Mechanisms of action). Real-time sample tracking; recording and security of linkage codes for samples to clinical data. Subproject 3 (Costs and cost-effectiveness). Cost data acquisition; Monitoring of data quality and integrity. All subprojects. Database development; Data entry and analysis; Data confidentiality.